{
"NDC": [
{
"NDCCode": "70385-2003-3",
"PackageDescription": "3 AMPULE in 1 BAG (70385-2003-3) > .33 mL in 1 AMPULE",
"NDC11Code": "70385-2003-03",
"ProductNDC": "70385-2003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ammonia Inhalants",
"NonProprietaryName": "Ammonia Inhalants",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19760214",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sina Health Inc",
"SubstanceName": "AMMONIA",
"StrengthNumber": ".045",
"StrengthUnit": "g/.3mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20160418",
"SamplePackage": "N",
"IndicationAndUsage": "To prevent or treat fainting."
},
{
"NDCCode": "70385-2009-1",
"PackageDescription": "1 CASE in 1 BAG (70385-2009-1) > 1 SYRINGE, GLASS in 1 CASE > .3 mL in 1 SYRINGE, GLASS",
"NDC11Code": "70385-2009-01",
"ProductNDC": "70385-2009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020800",
"LabelerName": "Sina Health Inc",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170703",
"SamplePackage": "N",
"IndicationAndUsage": "Epinephrine injection, USP auto-injector is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media), and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine injection, USP auto-injector is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria, or angioedema. Epinephrine injection, USP auto-injector is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.",
"Description": "Epinephrine injection, USP auto-injector 0.3 mg and 0.15 mg is an auto-injector and a combination product containing drug and device components. Each epinephrine injection, USP auto-injector 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP (0.3 mL) in a sterile solution. Each epinephrine injection, USP auto-injector 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP (0.15 mL) in a sterile solution. Epinephrine injection, USP auto-injector 0.3 mg and epinephrine injection, USP auto-injector 0.15 mg each contain 1.1 mL of epinephrine solution. 0.3 mL and 0.15 mL epinephrine solution are dispensed for epinephrine injection, USP auto-injector 0.3 mg and epinephrine injection, USP auto-injector 0.15 mg, respectively, when activated. The solution remaining after activation is not available for future use and should be discarded. Each 0.3 mL in epinephrine injection, USP auto-injector 0.3 mg contains 0.3 mg epinephrine, 2.6 mg sodium chloride, not more than 1.5 mg chlorobutanol, 0.45 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0. Each 0.15 mL in epinephrine injection, USP auto-injector 0.15 mg contains 0.15 mg epinephrine, 1.3 mg sodium chloride, not more than 0.75 mg chlorobutanol, 0.225 sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of epinephrine injection, USP auto-injector with patients and caregivers prior to use [ see Patient Counseling Information ( 17) ]."
},
{
"NDCCode": "70385-2019-1",
"PackageDescription": "1 CONTAINER in 1 PACKAGE (70385-2019-1) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS",
"NDC11Code": "70385-2019-01",
"ProductNDC": "70385-2019",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine 0.3 Adults",
"NonProprietaryName": "Epinephrine 0.3 Adults",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20161215",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019430",
"LabelerName": "Sina Health Inc",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161215",
"SamplePackage": "N",
"IndicationAndUsage": "Epinephrine injection, USP auto-injectors are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine injection, USP auto-injectors are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. Epinephrine injection, USP auto-injectors are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.",
"Description": "Epinephrine injection, USP auto-injectors, 0.3 mg and 0.15 mg, are single-dose auto-injectors and combination products containing drug and device components. Each epinephrine injection, USP auto-injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each epinephrine injection, USP auto-injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.3 mg contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.15 mg contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of epinephrine injection, USP auto-injector with patients and caregivers prior to use [ see Patient Counseling Information (17)]."
},
{
"NDCCode": "70385-2020-1",
"PackageDescription": "1 CONTAINER in 1 PACKAGE (70385-2020-1) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS",
"NDC11Code": "70385-2020-01",
"ProductNDC": "70385-2020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine 0.15 Pediatrics",
"NonProprietaryName": "Epinephrine 0.15 Pediatrics",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20161215",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019430",
"LabelerName": "Sina Health Inc",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".15",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161215",
"SamplePackage": "N",
"IndicationAndUsage": "Epinephrine injection, USP auto-injectors are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine injection, USP auto-injectors are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. Epinephrine injection, USP auto-injectors are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.",
"Description": "Epinephrine injection, USP auto-injectors, 0.3 mg and 0.15 mg, are single-dose auto-injectors and combination products containing drug and device components. Each epinephrine injection, USP auto-injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each epinephrine injection, USP auto-injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.3 mg contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.15 mg contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of epinephrine injection, USP auto-injector with patients and caregivers prior to use [ see Patient Counseling Information (17)]."
},
{
"NDCCode": "70385-2022-1",
"PackageDescription": "1 CASE in 1 PACKAGE (70385-2022-1) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS",
"NDC11Code": "70385-2022-01",
"ProductNDC": "70385-2022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine 0.3 Adults",
"NonProprietaryName": "Epinephrine 0.3 Adults",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020800",
"LabelerName": "Sina Health Inc",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N",
"IndicationAndUsage": "Epinephrine injection is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media), and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine injection is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria, or angioedema. Epinephrine injection is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.",
"Description": "Epinephrine injection, USP 0.3 mg and 0.15 mg is an auto-injector and a combination product containing drug and device components. Each epinephrine injection, USP 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP (0.3 mL) in a sterile solution. Each epinephrine injection, USP 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP (0.15 mL) in a sterile solution. Epinephrine injection, USP 0.3 mg and epinephrine injection, USP 0.15 mg each contain 1.1 mL of epinephrine solution. 0.3 mL and 0.15 mL epinephrine solution are dispensed for epinephrine injection, USP 0.3 mg and epinephrine injection, USP 0.15 mg, respectively, when activated. The solution remaining after activation is not available for future use and should be discarded. Each 0.3 mL in epinephrine injection, USP 0.3 mg contains 0.3 mg epinephrine, 2.6 mg sodium chloride, not more than 1.5 mg chlorobutanol, 0.45 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0. Each 0.15 mL in epinephrine injection, USP 0.15 mg contains 0.15 mg epinephrine, 1.3 mg sodium chloride, not more than 0.75 mg chlorobutanol, 0.225 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of epinephrine injection, USP with patients and caregivers prior to use [see Patient Counseling Information ( 17) ]."
},
{
"NDCCode": "36987-2003-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-2003-3)",
"NDC11Code": "36987-2003-03",
"ProductNDC": "36987-2003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mucor Plumbeus",
"NonProprietaryName": "Mucor Plumbeus",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "MUCOR PLUMBEUS",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-2003-3",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (37662-2003-3) ",
"NDC11Code": "37662-2003-03",
"ProductNDC": "37662-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rumex Crispus",
"NonProprietaryName": "Rumex Crispus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221122",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "RUMEX CRISPUS ROOT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221122",
"SamplePackage": "N"
},
{
"NDCCode": "49817-2003-3",
"PackageDescription": "1 BOTTLE in 1 BOX (49817-2003-3) > 15 mL in 1 BOTTLE",
"NDC11Code": "49817-2003-03",
"ProductNDC": "49817-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lingerie De Peau Natural Perfection Foundation Skin-fusion Texture With Sunscreen Broad Spectrum Spf 20 02n Clair Light",
"NonProprietaryName": "Octinoxate, Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160413",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Guerlain",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "30; 31.6",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-11-11",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231"
},
{
"NDCCode": "50488-2003-1",
"PackageDescription": "1 KIT in 1 BOX (50488-2003-1) * 1.2 g in 1 CONTAINER (50488-1006-1) * 22.2 g in 1 JAR * 3 g in 1 CONTAINER (50488-1008-1) * 1.2 g in 1 CONTAINER (50488-1004-1) * 2.4 g in 1 CONTAINER (50488-1003-1)",
"NDC11Code": "50488-2003-01",
"ProductNDC": "50488-2003",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "A.a.g.c. In Teroderm Cream",
"DosageFormName": "KIT",
"StartMarketingDate": "20140501",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Alexso, Inc.",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55618-2003-3",
"PackageDescription": "5 BLISTER PACK in 1 PACKAGE (55618-2003-3) > 2 CAPSULE in 1 BLISTER PACK (55618-2003-2) > 600 mg in 1 CAPSULE (55618-2003-1)",
"NDC11Code": "55618-2003-03",
"ProductNDC": "55618-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Miracle Gyn (10 Tablets)",
"NonProprietaryName": "Allantoin",
"DosageFormName": "TABLET",
"RouteName": "VAGINAL",
"StartMarketingDate": "20160707",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Haudongchun Co., Ltd.",
"SubstanceName": "ALLANTOIN",
"StrengthNumber": ".11",
"StrengthUnit": "1/600mg",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": " Relieves the following symptoms: vaginal irritation, itching and burning, odor, vaginal dryness."
},
{
"NDCCode": "62991-2003-3",
"PackageDescription": "500 g in 1 JAR (62991-2003-3)",
"NDC11Code": "62991-2003-03",
"ProductNDC": "62991-2003",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aminophylline Anhydrous",
"DosageFormName": "POWDER",
"StartMarketingDate": "20100826",
"EndMarketingDate": "20190930",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "LETCO MEDICAL, LLC",
"SubstanceName": "AMINOPHYLLINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04"
},
{
"NDCCode": "65129-2003-0",
"PackageDescription": "3.5 kg in 1 BAG (65129-2003-0) ",
"NDC11Code": "65129-2003-00",
"ProductNDC": "65129-2003",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Levonorgestrel",
"DosageFormName": "POWDER",
"StartMarketingDate": "20030411",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ScinoPharm Taiwan Ltd.",
"SubstanceName": "LEVONORGESTREL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-03-06",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "11-APR-03"
},
{
"NDCCode": "67752-2003-3",
"PackageDescription": "6 mL in 1 POUCH (67752-2003-3)",
"NDC11Code": "67752-2003-03",
"ProductNDC": "67752-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amsure",
"ProprietaryNameSuffix": "Three Povidone-iodine Swabsticks",
"NonProprietaryName": "Povidone-iodine",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120106",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "Amsino International, Inc.",
"SubstanceName": "POVIDONE-IODINE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "68258-2003-3",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68258-2003-3)",
"NDC11Code": "68258-2003-03",
"ProductNDC": "68258-2003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20091113",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078783",
"LabelerName": "Dispensing Solutions, Inc.",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tramadol hydrochloride ER tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.",
"Description": "Tramadol hydrochloride is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.8. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride Extended-Release (ER) tablets contain 100 mg or 200 mg of tramadol hydrochloride in an extended-release formulation. The tablets are white to off-white in color and contain the inactive ingredients colloidal silicone dioxide, dibutyl sebacate, ethylcellulose, magnesium stearate, polyvinyl alcohol, povidone K-90, and an imprinting agent, Opacode S-1-17823 black, which contains the following ingredients: shellac, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol, and ammonium hydroxide."
},
{
"NDCCode": "69866-2005-3",
"PackageDescription": "1 KIT in 1 CARTON (69866-2005-3) * 5 g in 1 VIAL, GLASS (69866-2003-1) * 50 g in 1 JAR (69866-2004-2) ",
"NDC11Code": "69866-2005-03",
"ProductNDC": "69866-2005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nexobrid",
"NonProprietaryName": "Anacaulase-bcdb",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221229",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761192",
"LabelerName": "Vericel Corporation",
"Status": "Active",
"LastUpdate": "2025-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221229",
"SamplePackage": "N",
"IndicationAndUsage": "NEXOBRID is indicated for eschar removal in adults and pediatric patients with deep partial thickness (DPT) and/or full thickness (FT) thermal burns. Limitations of Use. The safety and effectiveness of NEXOBRID have not been established for treatment of: 1 Chemical or electrical burns, 2 Burns on the face, perineum, or genitalia, 3 Burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease, 4 Circumferential burns, 5 Burns in patients with significant cardiopulmonary disease, including inhalation injury.",
"Description": "The drug substance in NEXOBRID, anacaulase-bcdb, is a mixture of proteolytic enzymes extracted from the stems of pineapple plants (Ananas comosus [L.] Merr.) that has been sterile filtered and lyophilized. The drug substance, anacaulase-bcdb, is composed mainly (80% to 95% w/w) of the proteins: stem bromelain, ananain, jacalin-like lectin, bromelain inhibitors, and phytocystatin inhibitor; and saccharides, as both free monosaccharides and the N-linked glycan of stem bromelain, and small molecule metabolites. The drug substance includes inactive buffer components containing acetic acid, ammonium sulfate, and Water for Injection. Each gram of lyophilized powder contains 0.97 grams of anacaulase-bcdb. NEXOBRID (anacaulase-bcdb) for topical gel is a botanical drug product supplied as a sterile, preservative-free, lyophilized powder in a single-dose glass vial that must be mixed in a gel vehicle supplied in a single-dose glass jar prior to application. Mixture of either 2 grams of lyophilized powder (containing 1.94 grams of anacaulase-bcdb) or 5 grams of lyophilized powder (containing 4.85 grams of anacaulase-bcdb) in 20 grams or 50 grams of gel vehicle, respectively, provides an 8.8% w/w, yellowish white to light brown opaque gel for topical use. The pH of the topical gel mixture is approximately 6.2 to 6.7. The co-packaged 20 gram or 50 gram jar of the sterile, preservative-free gel vehicle contains carbomer 980, dibasic sodium phosphate, sodium hydroxide, and Water for Injection."
},
{
"NDCCode": "73720-2003-3",
"PackageDescription": "10000 mL in 1 CASE (73720-2003-3) ",
"NDC11Code": "73720-2003-03",
"ProductNDC": "73720-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sol-m Alcohol Swabs Medium (folded) Non Sterile",
"NonProprietaryName": "Isopropyl Alcohol 70%",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Sol-Millennium Medical Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200731",
"SamplePackage": "N",
"IndicationAndUsage": "For preparation of the skin prior to an injection."
},
{
"NDCCode": "74351-2003-3",
"PackageDescription": "100 mL in 1 BOTTLE, DISPENSING (74351-2003-3) ",
"NDC11Code": "74351-2003-03",
"ProductNDC": "74351-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hemirus Hand Clinic Gel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200203",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Woosin Cosmetics Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "76.448",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-04-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200203",
"SamplePackage": "N"
},
{
"NDCCode": "77419-2003-1",
"PackageDescription": "3.785 L in 1 BOTTLE (77419-2003-1) ",
"NDC11Code": "77419-2003-01",
"ProductNDC": "77419-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amass Basilisk Breath Hand Sanitizer Serum",
"NonProprietaryName": "Basilisk Breath",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200908",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "AMASS Brands, Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "2.781",
"StrengthUnit": "L/3.785L",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200908",
"SamplePackage": "N",
"IndicationAndUsage": "USE Hand sanitizer to help reduce disease-causing bacteria."
},
{
"NDCCode": "0067-2003-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (0067-2003-01) / 100 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00067-2003-01",
"ProductNDC": "0067-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excedrin",
"ProprietaryNameSuffix": "Extra Strength Headache",
"NonProprietaryName": "Acetaminophen, Aspirin (nsaid), Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-01-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": " temporarily relieves minor aches and pains due to: 1 headache, 2 a cold, 3 arthritis, 4 muscular aches, 5 toothache, 6 premenstrual and menstrual cramps."
},
{
"NDCCode": "0067-2003-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (0067-2003-02) / 200 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00067-2003-02",
"ProductNDC": "0067-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excedrin",
"ProprietaryNameSuffix": "Extra Strength Headache",
"NonProprietaryName": "Acetaminophen, Aspirin (nsaid), Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-01-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": " temporarily relieves minor aches and pains due to: 1 headache, 2 a cold, 3 arthritis, 4 muscular aches, 5 toothache, 6 premenstrual and menstrual cramps."
},
{
"NDCCode": "11822-2003-1",
"PackageDescription": "332 mL in 1 BOTTLE, PLASTIC (11822-2003-1) ",
"NDC11Code": "11822-2003-01",
"ProductNDC": "11822-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Simplify Clean And Protect Cool Splash Lhs",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250116",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "RITE AID CORPORATION",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "130",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250116",
"SamplePackage": "N",
"IndicationAndUsage": "For Hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "53877-008-51",
"PackageDescription": "24 BAG in 1 CASE (53877-008-51) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG",
"NDC11Code": "53877-0008-51",
"ProductNDC": "53877-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100505",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN880217",
"LabelerName": "Terumo Corporation",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20100505",
"SamplePackage": "N",
"IndicationAndUsage": "Issued 6/03 TERUFLEX® BLOOD BAG SYSTEM With DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Rx ONLY.The Diversion Blood Sampling Arm is intended to divert and collect blood for obtaining donor test samples. For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam. Intended for the collection, processing and preservation of human blood and components.PRECAUTIONS Do not use unless the solutions are clear. Avoid excessive heat and direct sunlight. Protect from freezing. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). The blood bag configuration is specified on the blister pack label.CAUTION Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) or equivalentVENOJECT® ll Multi-Sample Luer Adapter (code MN *2000T) or equivalentEvacuated Blood Collection Tubes (glass or plastic)1. Prepare the blood bag following your institution's standard operating procedures.2. If applicable, make a loose knot in the donor tubing below the \"Y\" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.3. Temporarily clamp the donor tubing between the phlebotomy needle and the \"Y\".4. Close the White Clamp below the diversion pouch.5. Tube Holder/Luer Adapter Assembly:a) Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig.1).Insert Fig. 1 hereb) Twist and snap to remove the blue port cap at the end of the Diversion Blood sampling Arm (Fig. 2a).c) Connect the multi-sample luer adapter to the female luer port. (Fig. 2b)NOTE: Alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.Insert Fig. 2a and 2b here6. Suspend the collection bag as far as possible below the donor's arm.7. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.8. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.CAUTION Do not touch the needle after removing the needle protector. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.9. If using a needle safety device, follow the manufacturer's instructions to secure the device in place.10. Appropriately secure donor tubing to donor's arm.11. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in linewith the notches, the diversion pouch is full. (Fig. 3a)NOTE: The approximate fill volume of the pouch at the notches is 35 mL.12. Permanently seal the tubing between the \"Y\" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (Fig. 3b)13. To initiate blood flow into the collection bag, break the CLlKTIP between the \"Y\" and the primary bag.14. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b)CAUTION Do not collect donor test samples until the tubing between the \"Y\" and the diversion pouch is permanently sealed.a) Open the White Clamp on the tubing below the pouch to open the pathway for sampling.b) Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. Assure that any air in the pouch is at the top and will not enter theblood collection tubes.c) Insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent sealprior to removing the pouch.Insert Fig. 3a and 3b here15. Once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. Collect labeled volume of blood (+/–10%).17. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot andthe CLlKTIP below the \"Y\". Various methods may be used to seal tubing.18. Release pressure on the donor's arm and remove the needle. If using a needle safety device, follow the manufacturer's instructions to remove the needle. Sever the donor tubing between the two seals previously made below the CLlKTIP and \"Y\".CAUTION Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.19. Immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed.20. Strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. Seal on or near the X marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing.21. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions after removal of plasma:a) Within 8 hours of whole blood collection, if components are prepared.b) Within 72 hours of collection if whole blood is refrigerated immediately following collection.22. Centrifuge the unit to separate red cells from plasma.23. Break the CLlKTIP of primary collection bag and transfer the plasma into the satellite bag. Clamp transfer tubing of satellite bag.24. Break the CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between sealsand separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.25. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.26. Store AS-5 Red Blood Cells between 1-6°C.27. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open blister package, peel cover film back four fifths of its length. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.Insert Fig. 4 hereCAUTIONSThe packet of AGELESS contained in this package absorbs oxygen and generates heat on removal. Handle it with care. Dispose with packet in tray. Do not dispose with wastes containing volatile or flammable materials. Discard AGELESS packet without opening.N-BB-OP-A2(DB) 1TERUMO® MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN®: Registered Trademark Diversion Blood Sampling Arm and CLIKTIP are trademarks of TERUMO CORPORATION.© TERUMO CORPORATION 2003 03F10."
},
{
"NDCCode": "53877-008-61",
"PackageDescription": "24 BAG in 1 CASE (53877-008-61) > 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG",
"NDC11Code": "53877-0008-61",
"ProductNDC": "53877-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100505",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN880217",
"LabelerName": "Terumo Corporation",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20100505",
"SamplePackage": "N",
"IndicationAndUsage": "Issued 6/03 TERUFLEX® BLOOD BAG SYSTEM With DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Rx ONLY.The Diversion Blood Sampling Arm is intended to divert and collect blood for obtaining donor test samples. For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam. Intended for the collection, processing and preservation of human blood and components.PRECAUTIONS Do not use unless the solutions are clear. Avoid excessive heat and direct sunlight. Protect from freezing. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). The blood bag configuration is specified on the blister pack label.CAUTION Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) or equivalentVENOJECT® ll Multi-Sample Luer Adapter (code MN *2000T) or equivalentEvacuated Blood Collection Tubes (glass or plastic)1. Prepare the blood bag following your institution's standard operating procedures.2. If applicable, make a loose knot in the donor tubing below the \"Y\" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.3. Temporarily clamp the donor tubing between the phlebotomy needle and the \"Y\".4. Close the White Clamp below the diversion pouch.5. Tube Holder/Luer Adapter Assembly:a) Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig.1).Insert Fig. 1 hereb) Twist and snap to remove the blue port cap at the end of the Diversion Blood sampling Arm (Fig. 2a).c) Connect the multi-sample luer adapter to the female luer port. (Fig. 2b)NOTE: Alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.Insert Fig. 2a and 2b here6. Suspend the collection bag as far as possible below the donor's arm.7. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.8. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.CAUTION Do not touch the needle after removing the needle protector. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.9. If using a needle safety device, follow the manufacturer's instructions to secure the device in place.10. Appropriately secure donor tubing to donor's arm.11. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in linewith the notches, the diversion pouch is full. (Fig. 3a)NOTE: The approximate fill volume of the pouch at the notches is 35 mL.12. Permanently seal the tubing between the \"Y\" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (Fig. 3b)13. To initiate blood flow into the collection bag, break the CLlKTIP between the \"Y\" and the primary bag.14. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b)CAUTION Do not collect donor test samples until the tubing between the \"Y\" and the diversion pouch is permanently sealed.a) Open the White Clamp on the tubing below the pouch to open the pathway for sampling.b) Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. Assure that any air in the pouch is at the top and will not enter theblood collection tubes.c) Insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent sealprior to removing the pouch.Insert Fig. 3a and 3b here. 15. Once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. Collect labeled volume of blood (+/–10%).17. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot andthe CLlKTIP below the \"Y\". Various methods may be used to seal tubing.18. Release pressure on the donor's arm and remove the needle. If using a needle safety device, follow the manufacturer's instructions to remove the needle. Sever the donor tubing between the two seals previously made below the CLlKTIP and \"Y\".CAUTION Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.19. Immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed.20. Strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. Seal on or near the X marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing.21. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions after removal of plasma:a) Within 8 hours of whole blood collection, if components are prepared.b) Within 72 hours of collection if whole blood is refrigerated immediately following collection.22. Centrifuge the unit to separate red cells from plasma.23. Break the CLlKTIP of primary collection bag and transfer the plasma into the satellite bag. Clamp transfer tubing of satellite bag.24. Break the CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between sealsand separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.25. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.26. Store AS-5 Red Blood Cells between 1-6°C.27. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open blister package, peel cover film back four fifths of its length. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.Insert Fig. 4 here. CAUTIONSThe packet of AGELESS contained in this package absorbs oxygen and generates heat on removal. Handle it with care. Dispose with packet in tray. Do not dispose with wastes containing volatile or flammable materials. Discard AGELESS packet without opening.N-BB-OP-A2(DB) 1TERUMO® MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN®: Registered Trademark Diversion Blood Sampling Arm and CLIKTIP are trademarks of TERUMO CORPORATION.© TERUMO CORPORATION 2003 03F10."
},
{
"NDCCode": "53877-008-81",
"PackageDescription": "18 BAG in 1 CASE (53877-008-81) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG",
"NDC11Code": "53877-0008-81",
"ProductNDC": "53877-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative",
"NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20100505",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "BN880217",
"LabelerName": "Terumo Corporation",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20100505",
"SamplePackage": "N",
"IndicationAndUsage": "Issued 6/03 TERUFLEX® BLOOD BAG SYSTEM With DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Rx ONLY.The Diversion Blood Sampling Arm is intended to divert and collect blood for obtaining donor test samples. For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam. Intended for the collection, processing and preservation of human blood and components.PRECAUTIONS Do not use unless the solutions are clear. Avoid excessive heat and direct sunlight. Protect from freezing. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). The blood bag configuration is specified on the blister pack label.CAUTION Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) or equivalentVENOJECT® ll Multi-Sample Luer Adapter (code MN *2000T) or equivalentEvacuated Blood Collection Tubes (glass or plastic)1. Prepare the blood bag following your institution's standard operating procedures.2. If applicable, make a loose knot in the donor tubing below the \"Y\" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.3. Temporarily clamp the donor tubing between the phlebotomy needle and the \"Y\".4. Close the White Clamp below the diversion pouch.5. Tube Holder/Luer Adapter Assembly:a) Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig.1).Insert Fig. 1 here. b) Twist and snap to remove the blue port cap at the end of the Diversion Blood sampling Arm (Fig. 2a).c) Connect the multi-sample luer adapter to the female luer port. (Fig. 2b)NOTE: Alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.Insert Fig. 2a and 2b here. 6. Suspend the collection bag as far as possible below the donor's arm.7. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.8. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.CAUTION Do not touch the needle after removing the needle protector. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.9. If using a needle safety device, follow the manufacturer's instructions to secure the device in place.10. Appropriately secure donor tubing to donor's arm.11. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in linewith the notches, the diversion pouch is full. (Fig. 3a)NOTE: The approximate fill volume of the pouch at the notches is 35 mL.12. Permanently seal the tubing between the \"Y\" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (Fig. 3b)13. To initiate blood flow into the collection bag, break the CLlKTIP between the \"Y\" and the primary bag.14. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b)CAUTION Do not collect donor test samples until the tubing between the \"Y\" and the diversion pouch is permanently sealed.a) Open the White Clamp on the tubing below the pouch to open the pathway for sampling.b) Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. Assure that any air in the pouch is at the top and will not enter theblood collection tubes.c) Insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent sealprior to removing the pouch.Insert Fig. 3a and 3b here. 15. Once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. Collect labeled volume of blood (+/–10%).17. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot andthe CLlKTIP below the \"Y\". Various methods may be used to seal tubing.18. Release pressure on the donor's arm and remove the needle. If using a needle safety device, follow the manufacturer's instructions to remove the needle. Sever the donor tubing between the two seals previously made below the CLlKTIP and \"Y\".CAUTION Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.19. Immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed.20. Strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. Seal on or near the X marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing.21. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions after removal of plasma:a) Within 8 hours of whole blood collection, if components are prepared.b) Within 72 hours of collection if whole blood is refrigerated immediately following collection.22. Centrifuge the unit to separate red cells from plasma.23. Break the CLlKTIP of primary collection bag and transfer the plasma into the satellite bag. Clamp transfer tubing of satellite bag.24. Break the CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between sealsand separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.25. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.26. Store AS-5 Red Blood Cells between 1-6°C.27. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open blister package, peel cover film back four fifths of its length. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.Insert Fig. 4 here. CAUTIONSThe packet of AGELESS contained in this package absorbs oxygen and generates heat on removal. Handle it with care. Dispose with packet in tray. Do not dispose with wastes containing volatile or flammable materials. Discard AGELESS packet without opening.N-BB-OP-A2(DB) 1TERUMO® MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN®: Registered Trademark Diversion Blood Sampling Arm and CLIKTIP are trademarks of TERUMO CORPORATION.© TERUMO CORPORATION 2003 03F10."
},
{
"NDCCode": "55714-2003-4",
"PackageDescription": "50 g in 1 BOTTLE, PUMP (55714-2003-4)",
"NDC11Code": "55714-2003-04",
"ProductNDC": "55714-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bee - Bug Bite",
"NonProprietaryName": "Pulex Irritans, Tarentula Cubensis, Apis Mel., Aranea Diadema, Arnica, Formica, Grindelia, Hypericum, Lachesis, Latrodectus Mactans, Ledum, Lycopodium, Mezereum, Rhus Toxicodendron, Tarentula Hispana, Theridion, Vespa Crabro, Calendula, Echinacea, Hamamelis, Solidago",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130801",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "PULEX IRRITANS; CITHARACANTHUS SPINICRUS; APIS MELLIFERA; ARANEUS DIADEMATUS; ARNICA MONTANA; FORMICA RUFA; GRINDELIA HIRSUTULA FLOWERING TOP; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; LYCOSA TARANTULA; THERIDION CURASSAVICUM; VESPA CRABRO; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Bee - Bug Bite Cream: Formulated for symptoms associated with bites and stings such as pain, burning, itching and swelling."
},
{
"NDCCode": "70385-2002-1",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (70385-2002-1) > 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "70385-2002-01",
"ProductNDC": "70385-2002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flumazenil",
"NonProprietaryName": "Flumazenil",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20070101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078527",
"LabelerName": "Sina Health Inc",
"SubstanceName": "FLUMAZENIL",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20180702",
"SamplePackage": "N",
"IndicationAndUsage": "Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.",
"Description": "Flumazenil Injection, USP is a benzodiazepine receptor antagonist. Chemically, flumazenil is ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a](1,4) benzodiazepine-3-carboxylate. Flumazenil has an imidazobenzodiazepine structure, a calculated molecular weight of 303.3, and the following structural formula. Flumazenil is a white to off-white crystalline compound with an octanol: buffer partition coefficient of 14 to 1 at pH 7.4. It is insoluble in water but slightly soluble in acidic aqueous solutions. Flumazenil injection is available as a sterile parenteral dosage form for intravenous administration. Each mL contains 0.1 mg of flumazenil compounded with 1.8 mg of methylparaben, 0.2 mg of propylparaben, 0.9% sodium chloride, 0.01% edetate disodium, and 0.01% acetic acid; the pH is adjusted to approximately 4 with hydrochloric acid and/or, if necessary, sodium hydroxide."
},
{
"NDCCode": "70385-2005-2",
"PackageDescription": "2 PACKET in 1 BAG (70385-2005-2) > 2 TABLET, FILM COATED in 1 PACKET",
"NDC11Code": "70385-2005-02",
"ProductNDC": "70385-2005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110725",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Sina Health Inc",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170703",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves minor aches and pains associated with: 1 headache , 2 minor arthritis pain , 3 common cold , 4 menstrual cramps , 5 muscular aches , 6 backache , 7 toothache ."
},
{
"NDCCode": "70385-2006-2",
"PackageDescription": "2 PACKET in 1 PACKAGE (70385-2006-2) / 2 TABLET, FILM COATED in 1 PACKET",
"NDC11Code": "70385-2006-02",
"ProductNDC": "70385-2006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin Packs",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200720",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Sina Health Inc",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200720",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves: 1 headache, 2 toothache, 3 pain and fever of colds, 4 muscle pain, 5 menstrual pain, 6 minor pain of arthritis."
},
{
"NDCCode": "70385-2007-2",
"PackageDescription": "2 VIAL in 1 PACKAGE (70385-2007-2) > 1 mL in 1 VIAL",
"NDC11Code": "70385-2007-02",
"ProductNDC": "70385-2007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diphenhydramine Hydrochloride",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19721127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080817",
"LabelerName": "Sina Health Inc",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170703",
"SamplePackage": "N",
"IndicationAndUsage": "Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical.",
"Description": "Diphenhydramine Hydrochloride Injection is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. Each mL contains diphenhydramine hydrochloride 50 mg and benzethonium chloride 100 mcg in Water for Injection. pH 4.0-6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment. The chemical name of diphenhydramine hydrochloride is 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. The structural formula is as follows. C 17H 21NO HCl MW 291.82. Diphenhydramine hydrochloride occurs as a white crystalline powder and is freely soluble in water and alcohol."
},
{
"NDCCode": "70385-2008-2",
"PackageDescription": "2 AMPULE in 1 BAG (70385-2008-2) > 1 mL in 1 AMPULE",
"NDC11Code": "70385-2008-02",
"ProductNDC": "70385-2008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20050908",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sina Health Inc",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170703",
"SamplePackage": "N",
"IndicationAndUsage": "Epinephrine is used to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of anesthetics. Its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock. Epinephrine is used as a hemostatic agent. It is also used in treating mucosal congestion of hay fever, rhinitis, and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness, urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents; in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine contractions. Epinephrine Injection can be utilized to prolong the action of anesthetics used in local and regional anesthesia.",
"Description": "Epinephrine Injection, USP 1:1000 is a sterile, nonpyrogenic solution. Each mL contains epinephrine 1 mg; sodium chloride 9 mg; sodium metabisulfite 0.9 mg added. May contain hydrochloric acid for pH adjustment. The solution contains no bacteriostat or antimicrobial agent. It is administered by the following routes: intravenous, intracardiac (left ventricular chamber), via endotracheal tube into the bronchial tree, subcutaneous or intramuscular. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4‑[1‑hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula. Sodium Chloride, USP is chemically designated NaCl, a white, crystalline compound freely soluble in water."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>70385-2003-3</NDCCode>
<PackageDescription>3 AMPULE in 1 BAG (70385-2003-3) > .33 mL in 1 AMPULE</PackageDescription>
<NDC11Code>70385-2003-03</NDC11Code>
<ProductNDC>70385-2003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ammonia Inhalants</ProprietaryName>
<NonProprietaryName>Ammonia Inhalants</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19760214</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sina Health Inc</LabelerName>
<SubstanceName>AMMONIA</SubstanceName>
<StrengthNumber>.045</StrengthNumber>
<StrengthUnit>g/.3mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To prevent or treat fainting.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70385-2009-1</NDCCode>
<PackageDescription>1 CASE in 1 BAG (70385-2009-1) > 1 SYRINGE, GLASS in 1 CASE > .3 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>70385-2009-01</NDC11Code>
<ProductNDC>70385-2009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100401</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020800</ApplicationNumber>
<LabelerName>Sina Health Inc</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Epinephrine injection, USP auto-injector is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media), and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine injection, USP auto-injector is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria, or angioedema. Epinephrine injection, USP auto-injector is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.</IndicationAndUsage>
<Description>Epinephrine injection, USP auto-injector 0.3 mg and 0.15 mg is an auto-injector and a combination product containing drug and device components. Each epinephrine injection, USP auto-injector 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP (0.3 mL) in a sterile solution. Each epinephrine injection, USP auto-injector 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP (0.15 mL) in a sterile solution. Epinephrine injection, USP auto-injector 0.3 mg and epinephrine injection, USP auto-injector 0.15 mg each contain 1.1 mL of epinephrine solution. 0.3 mL and 0.15 mL epinephrine solution are dispensed for epinephrine injection, USP auto-injector 0.3 mg and epinephrine injection, USP auto-injector 0.15 mg, respectively, when activated. The solution remaining after activation is not available for future use and should be discarded. Each 0.3 mL in epinephrine injection, USP auto-injector 0.3 mg contains 0.3 mg epinephrine, 2.6 mg sodium chloride, not more than 1.5 mg chlorobutanol, 0.45 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0. Each 0.15 mL in epinephrine injection, USP auto-injector 0.15 mg contains 0.15 mg epinephrine, 1.3 mg sodium chloride, not more than 0.75 mg chlorobutanol, 0.225 sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of epinephrine injection, USP auto-injector with patients and caregivers prior to use [ see Patient Counseling Information ( 17) ].</Description>
</NDC>
<NDC>
<NDCCode>70385-2019-1</NDCCode>
<PackageDescription>1 CONTAINER in 1 PACKAGE (70385-2019-1) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>70385-2019-01</NDC11Code>
<ProductNDC>70385-2019</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine 0.3 Adults</ProprietaryName>
<NonProprietaryName>Epinephrine 0.3 Adults</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20161215</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019430</ApplicationNumber>
<LabelerName>Sina Health Inc</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Epinephrine injection, USP auto-injectors are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine injection, USP auto-injectors are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. Epinephrine injection, USP auto-injectors are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.</IndicationAndUsage>
<Description>Epinephrine injection, USP auto-injectors, 0.3 mg and 0.15 mg, are single-dose auto-injectors and combination products containing drug and device components. Each epinephrine injection, USP auto-injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each epinephrine injection, USP auto-injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.3 mg contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.15 mg contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of epinephrine injection, USP auto-injector with patients and caregivers prior to use [ see Patient Counseling Information (17)].</Description>
</NDC>
<NDC>
<NDCCode>70385-2020-1</NDCCode>
<PackageDescription>1 CONTAINER in 1 PACKAGE (70385-2020-1) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>70385-2020-01</NDC11Code>
<ProductNDC>70385-2020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine 0.15 Pediatrics</ProprietaryName>
<NonProprietaryName>Epinephrine 0.15 Pediatrics</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20161215</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019430</ApplicationNumber>
<LabelerName>Sina Health Inc</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Epinephrine injection, USP auto-injectors are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine injection, USP auto-injectors are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. Epinephrine injection, USP auto-injectors are intended for immediate administration as emergency supportive therapy only and are not a substitute for immediate medical care.</IndicationAndUsage>
<Description>Epinephrine injection, USP auto-injectors, 0.3 mg and 0.15 mg, are single-dose auto-injectors and combination products containing drug and device components. Each epinephrine injection, USP auto-injector, 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP 0.3 mg/0.3 mL in a sterile solution. Each epinephrine injection, USP auto-injector, 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP 0.15 mg/0.3 mL in a sterile solution. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.3 mg contains 0.3 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Each 0.3 mL in the epinephrine injection, USP auto-injector, 0.15 mg contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4- Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP auto-injector if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of epinephrine injection, USP auto-injector with patients and caregivers prior to use [ see Patient Counseling Information (17)].</Description>
</NDC>
<NDC>
<NDCCode>70385-2022-1</NDCCode>
<PackageDescription>1 CASE in 1 PACKAGE (70385-2022-1) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>70385-2022-01</NDC11Code>
<ProductNDC>70385-2022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine 0.3 Adults</ProprietaryName>
<NonProprietaryName>Epinephrine 0.3 Adults</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20100401</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020800</ApplicationNumber>
<LabelerName>Sina Health Inc</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Epinephrine injection is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes bees, wasps, hornets, yellow jackets and fire ants), and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media), and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine injection is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria, or angioedema. Epinephrine injection is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.</IndicationAndUsage>
<Description>Epinephrine injection, USP 0.3 mg and 0.15 mg is an auto-injector and a combination product containing drug and device components. Each epinephrine injection, USP 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP (0.3 mL) in a sterile solution. Each epinephrine injection, USP 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP (0.15 mL) in a sterile solution. Epinephrine injection, USP 0.3 mg and epinephrine injection, USP 0.15 mg each contain 1.1 mL of epinephrine solution. 0.3 mL and 0.15 mL epinephrine solution are dispensed for epinephrine injection, USP 0.3 mg and epinephrine injection, USP 0.15 mg, respectively, when activated. The solution remaining after activation is not available for future use and should be discarded. Each 0.3 mL in epinephrine injection, USP 0.3 mg contains 0.3 mg epinephrine, 2.6 mg sodium chloride, not more than 1.5 mg chlorobutanol, 0.45 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0. Each 0.15 mL in epinephrine injection, USP 0.15 mg contains 0.15 mg epinephrine, 1.3 mg sodium chloride, not more than 0.75 mg chlorobutanol, 0.225 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace epinephrine injection, USP if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles. Thoroughly review the patient instructions and operation of epinephrine injection, USP with patients and caregivers prior to use [see Patient Counseling Information ( 17) ].</Description>
</NDC>
<NDC>
<NDCCode>36987-2003-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-2003-3)</PackageDescription>
<NDC11Code>36987-2003-03</NDC11Code>
<ProductNDC>36987-2003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mucor Plumbeus</ProprietaryName>
<NonProprietaryName>Mucor Plumbeus</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>MUCOR PLUMBEUS</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-2003-3</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (37662-2003-3) </PackageDescription>
<NDC11Code>37662-2003-03</NDC11Code>
<ProductNDC>37662-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rumex Crispus</ProprietaryName>
<NonProprietaryName>Rumex Crispus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221122</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>RUMEX CRISPUS ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49817-2003-3</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (49817-2003-3) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>49817-2003-03</NDC11Code>
<ProductNDC>49817-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lingerie De Peau Natural Perfection Foundation Skin-fusion Texture With Sunscreen Broad Spectrum Spf 20 02n Clair Light</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160413</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Guerlain</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>30; 31.6</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-11-11</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50488-2003-1</NDCCode>
<PackageDescription>1 KIT in 1 BOX (50488-2003-1) * 1.2 g in 1 CONTAINER (50488-1006-1) * 22.2 g in 1 JAR * 3 g in 1 CONTAINER (50488-1008-1) * 1.2 g in 1 CONTAINER (50488-1004-1) * 2.4 g in 1 CONTAINER (50488-1003-1)</PackageDescription>
<NDC11Code>50488-2003-01</NDC11Code>
<ProductNDC>50488-2003</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>A.a.g.c. In Teroderm Cream</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140501</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Alexso, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55618-2003-3</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 PACKAGE (55618-2003-3) > 2 CAPSULE in 1 BLISTER PACK (55618-2003-2) > 600 mg in 1 CAPSULE (55618-2003-1)</PackageDescription>
<NDC11Code>55618-2003-03</NDC11Code>
<ProductNDC>55618-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Miracle Gyn (10 Tablets)</ProprietaryName>
<NonProprietaryName>Allantoin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20160707</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Haudongchun Co., Ltd.</LabelerName>
<SubstanceName>ALLANTOIN</SubstanceName>
<StrengthNumber>.11</StrengthNumber>
<StrengthUnit>1/600mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage> Relieves the following symptoms: vaginal irritation, itching and burning, odor, vaginal dryness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62991-2003-3</NDCCode>
<PackageDescription>500 g in 1 JAR (62991-2003-3)</PackageDescription>
<NDC11Code>62991-2003-03</NDC11Code>
<ProductNDC>62991-2003</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Aminophylline Anhydrous</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20100826</StartMarketingDate>
<EndMarketingDate>20190930</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>LETCO MEDICAL, LLC</LabelerName>
<SubstanceName>AMINOPHYLLINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>65129-2003-0</NDCCode>
<PackageDescription>3.5 kg in 1 BAG (65129-2003-0) </PackageDescription>
<NDC11Code>65129-2003-00</NDC11Code>
<ProductNDC>65129-2003</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Levonorgestrel</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20030411</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>ScinoPharm Taiwan Ltd.</LabelerName>
<SubstanceName>LEVONORGESTREL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-03-06</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-APR-03</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>67752-2003-3</NDCCode>
<PackageDescription>6 mL in 1 POUCH (67752-2003-3)</PackageDescription>
<NDC11Code>67752-2003-03</NDC11Code>
<ProductNDC>67752-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amsure</ProprietaryName>
<ProprietaryNameSuffix>Three Povidone-iodine Swabsticks</ProprietaryNameSuffix>
<NonProprietaryName>Povidone-iodine</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120106</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>Amsino International, Inc.</LabelerName>
<SubstanceName>POVIDONE-IODINE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>68258-2003-3</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68258-2003-3)</PackageDescription>
<NDC11Code>68258-2003-03</NDC11Code>
<ProductNDC>68258-2003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091113</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078783</ApplicationNumber>
<LabelerName>Dispensing Solutions, Inc.</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tramadol hydrochloride ER tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.</IndicationAndUsage>
<Description>Tramadol hydrochloride is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is. The molecular weight of tramadol hydrochloride is 299.8. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride Extended-Release (ER) tablets contain 100 mg or 200 mg of tramadol hydrochloride in an extended-release formulation. The tablets are white to off-white in color and contain the inactive ingredients colloidal silicone dioxide, dibutyl sebacate, ethylcellulose, magnesium stearate, polyvinyl alcohol, povidone K-90, and an imprinting agent, Opacode S-1-17823 black, which contains the following ingredients: shellac, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol, and ammonium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>69866-2005-3</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (69866-2005-3) * 5 g in 1 VIAL, GLASS (69866-2003-1) * 50 g in 1 JAR (69866-2004-2) </PackageDescription>
<NDC11Code>69866-2005-03</NDC11Code>
<ProductNDC>69866-2005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nexobrid</ProprietaryName>
<NonProprietaryName>Anacaulase-bcdb</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221229</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761192</ApplicationNumber>
<LabelerName>Vericel Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NEXOBRID is indicated for eschar removal in adults and pediatric patients with deep partial thickness (DPT) and/or full thickness (FT) thermal burns. Limitations of Use. The safety and effectiveness of NEXOBRID have not been established for treatment of: 1 Chemical or electrical burns, 2 Burns on the face, perineum, or genitalia, 3 Burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease, 4 Circumferential burns, 5 Burns in patients with significant cardiopulmonary disease, including inhalation injury.</IndicationAndUsage>
<Description>The drug substance in NEXOBRID, anacaulase-bcdb, is a mixture of proteolytic enzymes extracted from the stems of pineapple plants (Ananas comosus [L.] Merr.) that has been sterile filtered and lyophilized. The drug substance, anacaulase-bcdb, is composed mainly (80% to 95% w/w) of the proteins: stem bromelain, ananain, jacalin-like lectin, bromelain inhibitors, and phytocystatin inhibitor; and saccharides, as both free monosaccharides and the N-linked glycan of stem bromelain, and small molecule metabolites. The drug substance includes inactive buffer components containing acetic acid, ammonium sulfate, and Water for Injection. Each gram of lyophilized powder contains 0.97 grams of anacaulase-bcdb. NEXOBRID (anacaulase-bcdb) for topical gel is a botanical drug product supplied as a sterile, preservative-free, lyophilized powder in a single-dose glass vial that must be mixed in a gel vehicle supplied in a single-dose glass jar prior to application. Mixture of either 2 grams of lyophilized powder (containing 1.94 grams of anacaulase-bcdb) or 5 grams of lyophilized powder (containing 4.85 grams of anacaulase-bcdb) in 20 grams or 50 grams of gel vehicle, respectively, provides an 8.8% w/w, yellowish white to light brown opaque gel for topical use. The pH of the topical gel mixture is approximately 6.2 to 6.7. The co-packaged 20 gram or 50 gram jar of the sterile, preservative-free gel vehicle contains carbomer 980, dibasic sodium phosphate, sodium hydroxide, and Water for Injection.</Description>
</NDC>
<NDC>
<NDCCode>73720-2003-3</NDCCode>
<PackageDescription>10000 mL in 1 CASE (73720-2003-3) </PackageDescription>
<NDC11Code>73720-2003-03</NDC11Code>
<ProductNDC>73720-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sol-m Alcohol Swabs Medium (folded) Non Sterile</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol 70%</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200731</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Sol-Millennium Medical Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For preparation of the skin prior to an injection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>74351-2003-3</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, DISPENSING (74351-2003-3) </PackageDescription>
<NDC11Code>74351-2003-03</NDC11Code>
<ProductNDC>74351-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hemirus Hand Clinic Gel</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200203</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Woosin Cosmetics Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>76.448</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-04-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>77419-2003-1</NDCCode>
<PackageDescription>3.785 L in 1 BOTTLE (77419-2003-1) </PackageDescription>
<NDC11Code>77419-2003-01</NDC11Code>
<ProductNDC>77419-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Amass Basilisk Breath Hand Sanitizer Serum</ProprietaryName>
<NonProprietaryName>Basilisk Breath</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200908</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>AMASS Brands, Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>2.781</StrengthNumber>
<StrengthUnit>L/3.785L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USE Hand sanitizer to help reduce disease-causing bacteria.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-2003-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-2003-01) / 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-2003-01</NDC11Code>
<ProductNDC>0067-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Headache</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> temporarily relieves minor aches and pains due to: 1 headache, 2 a cold, 3 arthritis, 4 muscular aches, 5 toothache, 6 premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-2003-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-2003-02) / 200 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-2003-02</NDC11Code>
<ProductNDC>0067-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Headache</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> temporarily relieves minor aches and pains due to: 1 headache, 2 a cold, 3 arthritis, 4 muscular aches, 5 toothache, 6 premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-2003-1</NDCCode>
<PackageDescription>332 mL in 1 BOTTLE, PLASTIC (11822-2003-1) </PackageDescription>
<NDC11Code>11822-2003-01</NDC11Code>
<ProductNDC>11822-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Simplify Clean And Protect Cool Splash Lhs</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250116</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>RITE AID CORPORATION</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>130</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For Hand washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53877-008-51</NDCCode>
<PackageDescription>24 BAG in 1 CASE (53877-008-51) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0008-51</NDC11Code>
<ProductNDC>53877-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100505</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN880217</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Issued 6/03 TERUFLEX® BLOOD BAG SYSTEM With DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Rx ONLY.The Diversion Blood Sampling Arm is intended to divert and collect blood for obtaining donor test samples. For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam. Intended for the collection, processing and preservation of human blood and components.PRECAUTIONS Do not use unless the solutions are clear. Avoid excessive heat and direct sunlight. Protect from freezing. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). The blood bag configuration is specified on the blister pack label.CAUTION Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) or equivalentVENOJECT® ll Multi-Sample Luer Adapter (code MN *2000T) or equivalentEvacuated Blood Collection Tubes (glass or plastic)1. Prepare the blood bag following your institution's standard operating procedures.2. If applicable, make a loose knot in the donor tubing below the "Y" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.3. Temporarily clamp the donor tubing between the phlebotomy needle and the "Y".4. Close the White Clamp below the diversion pouch.5. Tube Holder/Luer Adapter Assembly:a) Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig.1).Insert Fig. 1 hereb) Twist and snap to remove the blue port cap at the end of the Diversion Blood sampling Arm (Fig. 2a).c) Connect the multi-sample luer adapter to the female luer port. (Fig. 2b)NOTE: Alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.Insert Fig. 2a and 2b here6. Suspend the collection bag as far as possible below the donor's arm.7. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.8. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.CAUTION Do not touch the needle after removing the needle protector. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.9. If using a needle safety device, follow the manufacturer's instructions to secure the device in place.10. Appropriately secure donor tubing to donor's arm.11. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in linewith the notches, the diversion pouch is full. (Fig. 3a)NOTE: The approximate fill volume of the pouch at the notches is 35 mL.12. Permanently seal the tubing between the "Y" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (Fig. 3b)13. To initiate blood flow into the collection bag, break the CLlKTIP between the "Y" and the primary bag.14. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b)CAUTION Do not collect donor test samples until the tubing between the "Y" and the diversion pouch is permanently sealed.a) Open the White Clamp on the tubing below the pouch to open the pathway for sampling.b) Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. Assure that any air in the pouch is at the top and will not enter theblood collection tubes.c) Insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent sealprior to removing the pouch.Insert Fig. 3a and 3b here15. Once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. Collect labeled volume of blood (+/–10%).17. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot andthe CLlKTIP below the "Y". Various methods may be used to seal tubing.18. Release pressure on the donor's arm and remove the needle. If using a needle safety device, follow the manufacturer's instructions to remove the needle. Sever the donor tubing between the two seals previously made below the CLlKTIP and "Y".CAUTION Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.19. Immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed.20. Strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. Seal on or near the X marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing.21. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions after removal of plasma:a) Within 8 hours of whole blood collection, if components are prepared.b) Within 72 hours of collection if whole blood is refrigerated immediately following collection.22. Centrifuge the unit to separate red cells from plasma.23. Break the CLlKTIP of primary collection bag and transfer the plasma into the satellite bag. Clamp transfer tubing of satellite bag.24. Break the CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between sealsand separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.25. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.26. Store AS-5 Red Blood Cells between 1-6°C.27. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open blister package, peel cover film back four fifths of its length. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.Insert Fig. 4 hereCAUTIONSThe packet of AGELESS contained in this package absorbs oxygen and generates heat on removal. Handle it with care. Dispose with packet in tray. Do not dispose with wastes containing volatile or flammable materials. Discard AGELESS packet without opening.N-BB-OP-A2(DB) 1TERUMO® MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN®: Registered Trademark Diversion Blood Sampling Arm and CLIKTIP are trademarks of TERUMO CORPORATION.© TERUMO CORPORATION 2003 03F10.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53877-008-61</NDCCode>
<PackageDescription>24 BAG in 1 CASE (53877-008-61) > 1 KIT in 1 BAG * 70 mL in 1 BAG * 111 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0008-61</NDC11Code>
<ProductNDC>53877-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100505</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN880217</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Issued 6/03 TERUFLEX® BLOOD BAG SYSTEM With DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Rx ONLY.The Diversion Blood Sampling Arm is intended to divert and collect blood for obtaining donor test samples. For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam. Intended for the collection, processing and preservation of human blood and components.PRECAUTIONS Do not use unless the solutions are clear. Avoid excessive heat and direct sunlight. Protect from freezing. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). The blood bag configuration is specified on the blister pack label.CAUTION Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) or equivalentVENOJECT® ll Multi-Sample Luer Adapter (code MN *2000T) or equivalentEvacuated Blood Collection Tubes (glass or plastic)1. Prepare the blood bag following your institution's standard operating procedures.2. If applicable, make a loose knot in the donor tubing below the "Y" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.3. Temporarily clamp the donor tubing between the phlebotomy needle and the "Y".4. Close the White Clamp below the diversion pouch.5. Tube Holder/Luer Adapter Assembly:a) Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig.1).Insert Fig. 1 hereb) Twist and snap to remove the blue port cap at the end of the Diversion Blood sampling Arm (Fig. 2a).c) Connect the multi-sample luer adapter to the female luer port. (Fig. 2b)NOTE: Alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.Insert Fig. 2a and 2b here6. Suspend the collection bag as far as possible below the donor's arm.7. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.8. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.CAUTION Do not touch the needle after removing the needle protector. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.9. If using a needle safety device, follow the manufacturer's instructions to secure the device in place.10. Appropriately secure donor tubing to donor's arm.11. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in linewith the notches, the diversion pouch is full. (Fig. 3a)NOTE: The approximate fill volume of the pouch at the notches is 35 mL.12. Permanently seal the tubing between the "Y" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (Fig. 3b)13. To initiate blood flow into the collection bag, break the CLlKTIP between the "Y" and the primary bag.14. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b)CAUTION Do not collect donor test samples until the tubing between the "Y" and the diversion pouch is permanently sealed.a) Open the White Clamp on the tubing below the pouch to open the pathway for sampling.b) Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. Assure that any air in the pouch is at the top and will not enter theblood collection tubes.c) Insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent sealprior to removing the pouch.Insert Fig. 3a and 3b here. 15. Once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. Collect labeled volume of blood (+/–10%).17. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot andthe CLlKTIP below the "Y". Various methods may be used to seal tubing.18. Release pressure on the donor's arm and remove the needle. If using a needle safety device, follow the manufacturer's instructions to remove the needle. Sever the donor tubing between the two seals previously made below the CLlKTIP and "Y".CAUTION Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.19. Immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed.20. Strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. Seal on or near the X marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing.21. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions after removal of plasma:a) Within 8 hours of whole blood collection, if components are prepared.b) Within 72 hours of collection if whole blood is refrigerated immediately following collection.22. Centrifuge the unit to separate red cells from plasma.23. Break the CLlKTIP of primary collection bag and transfer the plasma into the satellite bag. Clamp transfer tubing of satellite bag.24. Break the CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between sealsand separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.25. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.26. Store AS-5 Red Blood Cells between 1-6°C.27. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open blister package, peel cover film back four fifths of its length. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.Insert Fig. 4 here. CAUTIONSThe packet of AGELESS contained in this package absorbs oxygen and generates heat on removal. Handle it with care. Dispose with packet in tray. Do not dispose with wastes containing volatile or flammable materials. Discard AGELESS packet without opening.N-BB-OP-A2(DB) 1TERUMO® MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN®: Registered Trademark Diversion Blood Sampling Arm and CLIKTIP are trademarks of TERUMO CORPORATION.© TERUMO CORPORATION 2003 03F10.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>53877-008-81</NDCCode>
<PackageDescription>18 BAG in 1 CASE (53877-008-81) > 1 KIT in 1 BAG * 63 mL in 1 BAG * 100 mL in 1 BAG</PackageDescription>
<NDC11Code>53877-0008-81</NDC11Code>
<ProductNDC>53877-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Teruflex Blood Bag System With Diversion Blood Sampling Arm Anticoagulant Citrate Phosphate Dextrose (cpd) And Optisol (as-5) Red Cell Preservative</ProprietaryName>
<NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20100505</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>BN880217</ApplicationNumber>
<LabelerName>Terumo Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Issued 6/03 TERUFLEX® BLOOD BAG SYSTEM With DIVERSION BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTIONRead these instructions carefully before use. Rx ONLY.The Diversion Blood Sampling Arm is intended to divert and collect blood for obtaining donor test samples. For single use only. Sterile and non-pyrogenic fluid path. Sterilized by steam. Intended for the collection, processing and preservation of human blood and components.PRECAUTIONS Do not use unless the solutions are clear. Avoid excessive heat and direct sunlight. Protect from freezing. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). The blood bag configuration is specified on the blister pack label.CAUTION Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose.INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic techniqueMaterials Needed: VENOJECT® ll Tube Holder (code P-1316R) or equivalentVENOJECT® ll Multi-Sample Luer Adapter (code MN *2000T) or equivalentEvacuated Blood Collection Tubes (glass or plastic)1. Prepare the blood bag following your institution's standard operating procedures.2. If applicable, make a loose knot in the donor tubing below the "Y" and CLIKTIP (inline closure device) unless alternate methods are used to seal the tubing at the end of collection.3. Temporarily clamp the donor tubing between the phlebotomy needle and the "Y".4. Close the White Clamp below the diversion pouch.5. Tube Holder/Luer Adapter Assembly:a) Connect the VENOJECT II Multi-Sample Luer Adapter to the VENOJECT II Tube Holder (or equivalent) (Fig.1).Insert Fig. 1 here. b) Twist and snap to remove the blue port cap at the end of the Diversion Blood sampling Arm (Fig. 2a).c) Connect the multi-sample luer adapter to the female luer port. (Fig. 2b)NOTE: Alternatively, steps a, b and c (above) may be performed at any time during bag preparation or after the blood is collected into the diversion pouch.Insert Fig. 2a and 2b here. 6. Suspend the collection bag as far as possible below the donor's arm.7. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate to approximately 60 mmHg.8. Remove the needle cover and perform phlebotomy. Remove the temporary clamp on the donor tubing to permit blood flow into the Diversion Blood Sampling Arm pouch.CAUTION Do not touch the needle after removing the needle protector. Assure that the White Clamp below the pouch is closed prior to initiating phlebotomy.9. If using a needle safety device, follow the manufacturer's instructions to secure the device in place.10. Appropriately secure donor tubing to donor's arm.11. Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly (or port cap) down. When the level of blood in the pouch is approximately in linewith the notches, the diversion pouch is full. (Fig. 3a)NOTE: The approximate fill volume of the pouch at the notches is 35 mL.12. Permanently seal the tubing between the "Y" and the diversion pouch to maintain a closed system using an aluminum clip or a tube sealer approved for use with tubing connected to a donor. (Fig. 3b)13. To initiate blood flow into the collection bag, break the CLlKTIP between the "Y" and the primary bag.14. To avoid clot formation, collect samples as soon as possible from the diversion pouch as follows (Fig. 3b)CAUTION Do not collect donor test samples until the tubing between the "Y" and the diversion pouch is permanently sealed.a) Open the White Clamp on the tubing below the pouch to open the pathway for sampling.b) Position the diversion pouch with the notches up and the Tube Holder/Luer Adapter assembly down. Assure that any air in the pouch is at the top and will not enter theblood collection tubes.c) Insert vacuum blood collection tube firmly into the tube holder; when full, remove sample tube from holder. Repeat to collect additional samples.NOTE: The pouch may be removed after the donor test samples are collected. A second seal must be made between the diversion pouch and the permanent sealprior to removing the pouch.Insert Fig. 3a and 3b here. 15. Once samples are obtained, mix blood with anticoagulant in the primary bag and continue to mix at several intervals during collection. 16. Collect labeled volume of blood (+/–10%).17. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in step 2. Make a second seal between the first seal or knot andthe CLlKTIP below the "Y". Various methods may be used to seal tubing.18. Release pressure on the donor's arm and remove the needle. If using a needle safety device, follow the manufacturer's instructions to remove the needle. Sever the donor tubing between the two seals previously made below the CLlKTIP and "Y".CAUTION Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional procedures.19. Immediately after collection, invert the bag several times to assure blood and anticoagulant are well mixed.20. Strip blood from the donor tubing into the bag, mix well, and allow tubing to refill. Seal on or near the X marks on the donor tubing to provide numbered aliquots of anticoagulated blood for testing.21. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions after removal of plasma:a) Within 8 hours of whole blood collection, if components are prepared.b) Within 72 hours of collection if whole blood is refrigerated immediately following collection.22. Centrifuge the unit to separate red cells from plasma.23. Break the CLlKTIP of primary collection bag and transfer the plasma into the satellite bag. Clamp transfer tubing of satellite bag.24. Break the CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between sealsand separate from satellite bag(s).NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.25. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.26. Store AS-5 Red Blood Cells between 1-6°C.27. Infuse AS-5 Red Blood Cells within 42 days of collection.For further processing, use standard component processing techniques.To open blister package, peel cover film back four fifths of its length. After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.Insert Fig. 4 here. CAUTIONSThe packet of AGELESS contained in this package absorbs oxygen and generates heat on removal. Handle it with care. Dispose with packet in tray. Do not dispose with wastes containing volatile or flammable materials. Discard AGELESS packet without opening.N-BB-OP-A2(DB) 1TERUMO® MANUFACTURED BY: TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN MADE IN JAPAN®: Registered Trademark Diversion Blood Sampling Arm and CLIKTIP are trademarks of TERUMO CORPORATION.© TERUMO CORPORATION 2003 03F10.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-2003-4</NDCCode>
<PackageDescription>50 g in 1 BOTTLE, PUMP (55714-2003-4)</PackageDescription>
<NDC11Code>55714-2003-04</NDC11Code>
<ProductNDC>55714-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bee - Bug Bite</ProprietaryName>
<NonProprietaryName>Pulex Irritans, Tarentula Cubensis, Apis Mel., Aranea Diadema, Arnica, Formica, Grindelia, Hypericum, Lachesis, Latrodectus Mactans, Ledum, Lycopodium, Mezereum, Rhus Toxicodendron, Tarentula Hispana, Theridion, Vespa Crabro, Calendula, Echinacea, Hamamelis, Solidago</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>PULEX IRRITANS; CITHARACANTHUS SPINICRUS; APIS MELLIFERA; ARANEUS DIADEMATUS; ARNICA MONTANA; FORMICA RUFA; GRINDELIA HIRSUTULA FLOWERING TOP; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; TOXICODENDRON PUBESCENS LEAF; LYCOSA TARANTULA; THERIDION CURASSAVICUM; VESPA CRABRO; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>15; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Bee - Bug Bite Cream: Formulated for symptoms associated with bites and stings such as pain, burning, itching and swelling.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70385-2002-1</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BAG (70385-2002-1) > 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>70385-2002-01</NDC11Code>
<ProductNDC>70385-2002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flumazenil</ProprietaryName>
<NonProprietaryName>Flumazenil</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20070101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078527</ApplicationNumber>
<LabelerName>Sina Health Inc</LabelerName>
<SubstanceName>FLUMAZENIL</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.</IndicationAndUsage>
<Description>Flumazenil Injection, USP is a benzodiazepine receptor antagonist. Chemically, flumazenil is ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a](1,4) benzodiazepine-3-carboxylate. Flumazenil has an imidazobenzodiazepine structure, a calculated molecular weight of 303.3, and the following structural formula. Flumazenil is a white to off-white crystalline compound with an octanol: buffer partition coefficient of 14 to 1 at pH 7.4. It is insoluble in water but slightly soluble in acidic aqueous solutions. Flumazenil injection is available as a sterile parenteral dosage form for intravenous administration. Each mL contains 0.1 mg of flumazenil compounded with 1.8 mg of methylparaben, 0.2 mg of propylparaben, 0.9% sodium chloride, 0.01% edetate disodium, and 0.01% acetic acid; the pH is adjusted to approximately 4 with hydrochloric acid and/or, if necessary, sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>70385-2005-2</NDCCode>
<PackageDescription>2 PACKET in 1 BAG (70385-2005-2) > 2 TABLET, FILM COATED in 1 PACKET</PackageDescription>
<NDC11Code>70385-2005-02</NDC11Code>
<ProductNDC>70385-2005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110725</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Sina Health Inc</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves minor aches and pains associated with: 1 headache , 2 minor arthritis pain , 3 common cold , 4 menstrual cramps , 5 muscular aches , 6 backache , 7 toothache .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70385-2006-2</NDCCode>
<PackageDescription>2 PACKET in 1 PACKAGE (70385-2006-2) / 2 TABLET, FILM COATED in 1 PACKET</PackageDescription>
<NDC11Code>70385-2006-02</NDC11Code>
<ProductNDC>70385-2006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin Packs</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200720</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Sina Health Inc</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves: 1 headache, 2 toothache, 3 pain and fever of colds, 4 muscle pain, 5 menstrual pain, 6 minor pain of arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70385-2007-2</NDCCode>
<PackageDescription>2 VIAL in 1 PACKAGE (70385-2007-2) > 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>70385-2007-02</NDC11Code>
<ProductNDC>70385-2007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diphenhydramine Hydrochloride</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19721127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080817</ApplicationNumber>
<LabelerName>Sina Health Inc</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diphenhydramine Hydrochloride Injection is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical.</IndicationAndUsage>
<Description>Diphenhydramine Hydrochloride Injection is a sterile, nonpyrogenic solution for intravenous or deep intramuscular use as an antihistaminic agent. Each mL contains diphenhydramine hydrochloride 50 mg and benzethonium chloride 100 mcg in Water for Injection. pH 4.0-6.5; sodium hydroxide and/or hydrochloric acid added, if needed, for pH adjustment. The chemical name of diphenhydramine hydrochloride is 2-(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. The structural formula is as follows. C 17H 21NO HCl MW 291.82. Diphenhydramine hydrochloride occurs as a white crystalline powder and is freely soluble in water and alcohol.</Description>
</NDC>
<NDC>
<NDCCode>70385-2008-2</NDCCode>
<PackageDescription>2 AMPULE in 1 BAG (70385-2008-2) > 1 mL in 1 AMPULE</PackageDescription>
<NDC11Code>70385-2008-02</NDC11Code>
<ProductNDC>70385-2008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050908</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sina Health Inc</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170703</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Epinephrine is used to relieve respiratory distress due to bronchospasm, to provide rapid relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of anesthetics. Its cardiac effects may be of use in restoring cardiac rhythm in cardiac arrest due to various causes, but it is not used in cardiac failure or in hemorrhagic, traumatic, or cardiogenic shock. Epinephrine is used as a hemostatic agent. It is also used in treating mucosal congestion of hay fever, rhinitis, and acute sinusitis; to relieve bronchial asthmatic paroxysms; in syncope due to complete heart block or carotid sinus hypersensitivity; for symptomatic relief of serum sickness, urticaria, angioneurotic edema; for resuscitation in cardiac arrest following anesthetic accidents; in simple (open angle) glaucoma; for relaxation of uterine musculature and to inhibit uterine contractions. Epinephrine Injection can be utilized to prolong the action of anesthetics used in local and regional anesthesia.</IndicationAndUsage>
<Description>Epinephrine Injection, USP 1:1000 is a sterile, nonpyrogenic solution. Each mL contains epinephrine 1 mg; sodium chloride 9 mg; sodium metabisulfite 0.9 mg added. May contain hydrochloric acid for pH adjustment. The solution contains no bacteriostat or antimicrobial agent. It is administered by the following routes: intravenous, intracardiac (left ventricular chamber), via endotracheal tube into the bronchial tree, subcutaneous or intramuscular. Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4‑[1‑hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula. Sodium Chloride, USP is chemically designated NaCl, a white, crystalline compound freely soluble in water.</Description>
</NDC>
</NDCList>